Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper 29
`Entered: May 31, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., and AKORN INC.
`Petitioners,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01127 (8,685,930 B2)
`Case IPR2016-01128 (8,629,111 B2)
`Case IPR2016-01129 (8,642,556 B2)
`Case IPR2016-01130 (8,633,162 B2)
`Case IPR2016-01131 (8,648,048 B2)
`Case IPR2016-01132 (9,248,191 B2)
`_______________
`
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`ORDER
`Granting-in-part Petitioner’s Motion for Additional Discovery
`37 .F.R §§ 42.51(b)(2), 42.52(a)
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`Paper 29
`Entered: May 31, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., and AKORN INC.
`Petitioners,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01127 (8,685,930 B2)
`Case IPR2016-01128 (8,629,111 B2)
`Case IPR2016-01129 (8,642,556 B2)
`Case IPR2016-01130 (8,633,162 B2)
`Case IPR2016-01131 (8,648,048 B2)
`Case IPR2016-01132 (9,248,191 B2)
`_______________
`
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`ORDER
`Granting-in-part Petitioner’s Motion for Additional Discovery
`37 .F.R §§ 42.51(b)(2), 42.52(a)
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`
`INTRODUCTION
`Pursuant to our authorization, Petitioner filed a motion for additional
`discovery. Paper 221 (“Motion” or “Mot.”). Patent Owner filed an
`opposition. Papers 27 (“opposition” or “Opp.”). In its Motion, Petitioner
`requests an order requiring Patent Owner to produce (i) the phase 2 clinical
`trial (192371-001) data, (ii) the phase 3 clinical trial data (192371-002 and -
`003), and (iii) the pharmacokinetic (“PK”) data underlying Schiffman
`Exhibits B–F (Ex. 1004, 213–223), Attar Exhibits B–D (Ex. 1004, 237–
`242), and Sall Figures 1–4 (Ex. 1007).
`Additional discovery may be ordered if the party moving for the
`discovery shows “that such additional discovery is in the interests of
`justice.” 37 C.F.R. § 42.51(b)(2). The Board has identified five factors (“the
`Garmin factors”) important in determining whether additional discovery is
`in the interests of justice. Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`Case IPR2012-00001, slip op. at 6–7 (PTAB Mar. 5, 2013) (Paper 26)
`(informative). These factors are: (1) more than a possibility and mere
`allegation that something useful will be discovered; (2) requests that do not
`seek other party’s litigation positions and the underlying basis for those
`positions; (3) ability to generate equivalent information by other means; (4)
`easily understandable instructions; and (5) requests that are not overly
`burdensome to answer. Id. We address each of Petitioner’s requests in view
`of the Garmin factors below.
`
`
`1 Identical papers were filed in each of the identified cases. Hereinafter,
`reference will be made to papers filed in IPR2016-01127.
`
` 2
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`
`A. PK data underlying Schiffman Exhibits B–F and Attar
`Exhibits B–D
`Based on the specific facts of this case, we are persuaded that it is in
`the interest of justice to allow the requested discovery with regard to the PK
`data underlying Schiffman Exhibits B–F and Attar Exhibits B–D in order for
`Petitioner to develop fully its rebuttal to Patent Owner’s evidence of
`unexpected results. Here, the first Garmin factor is most relevant. Patent
`Owner relies upon the figures in the Schiffman and Attar declarations to
`support its response to Petitioner’s obviousness grounds. As noted by
`Petitioner, however, the figures “failed to provide the necessary parameters
`for scientific interpretation, including raw data values and error rates.” Mot.
`2 (citing Paper 3, 47–57). Thus, we agree with Petitioner that the underlying
`data is necessary to evaluate figures fully, will aid Petitioner’s rebuttal to
`Patent Owner’s arguments and evidence, and will afford Petitioner a fair
`cross-examination of Patent Owner’s witnesses. 37 C.F.R.
`§§ 42.51(b)(2)(i)-(ii). Accordingly, we find that there is more than a
`possibility that something useful will be discovered by granting Petitioner’s
`discovery request for this information. We further note that our rule § 42.65
`favors the disclosure of the underlying facts or data on which an expert’s
`testimony is based. 37 CFR § 42.65.
`Regarding the remaining Garmin factors, we acknowledge Patent
`Owner’s arguments, but find that the request does not seek to uncover an
`opponent’s litigation position (Garmin Factor 2), does not seek information
`that could be obtained through other means (Garmin Factor 3), is easily
`understood (Garmin Factor 4), and is limited in scope and does not place an
`undue burden on Patent Owner (Garmin Factor 5).
`
` 3
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`
`Accordingly, we grant Petitioner’s motion and order Patent Owner to
`produce the PK data underlying Schiffman Exhibits B–F and Attar Exhibits
`B–D.
`
`B. PK data underlying Sall Figures 1–4
`We deny Petitioner’s request as to the PK data underlying Sall Figures
`1–4. As noted by Patent Owner, Sall is a peer-reviewed publication that
`summarizes the efficacy data of Patent Owner’s phase 2 and phase 3 clinical
`trial studies. Opp. 1. Unlike the figures presented in the Schiffman and
`Attar declarations, Sall Figures 1–4 are shown with mean value and standard
`error rates. Ex. 1007, 635–636. Thus, Sall Figures 1–4 do not suffer from
`the same deficiencies identified by Petitioner in the exhibits of the
`Schiffman and Attar declarations. We otherwise agree with Patent Owner
`that Sall Figures 1–4 discloses the “necessary information to answer the
`question of whether the efficacy results are significant.” Opp. 1.
`Petitioner fails to identify any other deficiency in the manner in which
`Sall Figures 1–4 are presented. Accordingly, in view of the above, we are
`not persuaded that something useful will be discovered by granting
`Petitioner’s discovery request with regard to Sall Figures 1–4.
`
`C. Phase 2 Clinical Trial Data and Phase 3 Clinical Trial Data
`
`We deny Petitioner’s request as to phase 2 and phase 3 clinical trial
`data. Petitioner seems to suggest that the requested phase 2 and phase 3
`clinical trial data was used to produce Schiffman Exhibits B-F, Attar
`Exhibits B-D, and Sall Figures 1–4. Mot. 4. To the extent that this request
`overlaps Petitioner’s requests with regard to Schiffman Exhibits B-F, Attar
`Exhibits B-D, and Sall Figures 1–4, we addressed those requests above. To
`
` 4
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`the extent that Petitioner’s request does not overlap with its other requests,
`Petitioner’s request is overly broad and is not narrowly tailored to any
`specific issue in these proceedings. Accordingly, Petitioner’s request is
`unlikely to uncover something useful and is overly burdensome, thus failing
`Garmin Factors 1 and 5.
`
`ORDER
`
`Accordingly, it is:
`ORDERED that Patent Owner shall produce the pharmacokinetic
`(“PK”) data underlying Schiffman Exhibits B–F and Attar Exhibits B–D;
`and
`
`FURTHER ORDERED that Petitioner’s motion is denied as to all
`other requests for additional discovery.
`
`
`PETITIONER:
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`
`PATENT OWNER:
`
`Dorothy P. Whelan
`Michael Kane
`Fish & Richardson P.C.
`whelan@fr.com
`
` 5
`
`
`
`
`
`
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